Hair transplantation procedures are well-known, and typically involve (in a patient having male pattern baldness) harvesting donor hair grafts from the side and back fringe areas (donor areas) of the patient's scalp, and implanting them in a bald area (recipient area). Historically, the harvested grafts were relatively large (3-5 mm), although more recently, the donor grafts may be single follicular units. In particular, “follicular units” (also referred to herein as FU or FUs) are naturally occurring aggregates of 1-3 (and much less commonly, 4-5) closely spaced hair follicles that are distributed randomly over the surface of the scalp.
The follicular units may be classified, or “typed,” based on the number of hairs in the unit and identified in shorthand as an “F1” for a single hair follicular unit, an “F2” for a two hair follicular unit and so on for follicular units with 3-5 hairs. In some cases of multiple hair follicular units, the hairs may appear to emanate from a single follicle or point in the skin. In other cases, the hairs may exit the skin surface at slightly spaced apart positions, but converge into a single follicular unit beneath the skin. Referring to FIG. 1, a print of a digital image of an exemplary section of a human scalp 11 having a variety of types of follicular units is shown. For example, the follicular unit 17 has two hairs and is therefore an F2, while follicular unit 13 is an F1 since it has only a single hair.
There are several reasons it is important and desirable to count and classify follicular units in a region of interest on a body surface. For one, the number of follicular units can be used in the planning process for a transplantation procedure. For instance, if this number sets the limit on the number of follicular units in that area that can be harvested for transplantation. However, in many cases, the doctor may want to implant only a certain percentage of the follicular units available, thereby leaving some coverage in the area being harvested. In addition, in many hair restoration transplant procedures, certain classes of follicular units are preferred.
As for classification, there are several reasons it is important and desirable to identify and classify follicular units based on the number of hairs in the follicular unit. It may be desirable to utilize a variety of classes (also referred to as “types”) of follicular units to provide the desired attributes for the appearance of the transplanted hair. Such attributes can include the density of hair, the direction or orientation of hair, the particular mix of types of follicular units, and/or the appearance of randomness, among other possible attributes. An example of the use of various types of follicular units is as follows. It is preferable to transplant certain classes of follicular units into specific regions of the scalp. For example, single hair follicular units (F1s) are commonly implanted along the hairline that frames the face. Follicular units with more than one hair (F2s, F3s, etc.) are commonly implanted in the mid-scalp and crown. This arrangement of follicular unit distribution is thought to produce a more natural appearing aesthetic result.
Various procedures for hair transplantation have been previously disclosed, including both manual and mechanized to certain degrees of automation. In one well-known manual process, a linear portion of the scalp is removed from a donor area by dissection with a scalpel down into the fatty subcutaneous tissue. The strip is dissected (under a microscope) into the component follicular units, which are then implanted into a recipient area in respective puncture holes made by a needle. Forceps are typically used to grasp and place the follicular unit grafts into the needle puncture locations, although other instruments and methods are known for doing so.
In “Androgenetic Alopecia” (Springer 1996), M. Inaba & Y. Inaba disclose and describe a manual method for harvesting singular follicular units by positioning a hollow punch needle having a cutting edge and interior lumen with a diameter of 1 mm, which is about equal to the diameter of critical anatomical parts of a follicular unit. The needle punch is axially aligned with an axis of a follicular unit to be extracted and then advanced into the scalp to cut the scalp about the circumference of the selected follicular unit. Thereafter, the follicular units are easily removed, e.g., using forceps, for subsequent implantation into a recipient site with a specially devised insertion needle.
U.S. Pat. No. 6,585,746 discloses an automated hair transplantation system utilizing a robot, including a robotic arm and a hair follicle introducer associated with the robotic arm. A video system is used to produce a three-dimensional virtual image of the patient's scalp, which is used to plan the scalp locations that are to receive hair grafts implanted by the follicle introducer under the control of the robotic arm. The entire disclosure of U.S. Pat. No. 6,585,746 is incorporated herein by reference.
Automated systems and methods for transplanting are also disclosed in U.S. provisional patent application Ser. Nos. 60/722,521, filed Sep. 30, 2005, 60/753,602, filed Dec. 22, 2005, and 60/764,173, filed Jan. 31, 2006, and U.S. patent application Ser. Nos. 11/380,903, filed Apr. 28, 2006 (now published as US 2007/0078466) and Ser. No. 11/380,907, filed Apr. 28, 2006 (now published as US 2007/0106306). The foregoing applications are all hereby incorporated by reference into the present application in their entirety. For example, in U.S. patent application Ser. No. 11/380,907, referenced above, the disclosed system comprises a robotic arm having a harvesting and/or implantation tool mounted on the arm. One or more cameras are also mounted on the arm and are used to image the work space, such as a body surface. A processor is configured to receive and process images acquired by the cameras. A controller is operatively coupled to the processor and the robotic arm. The controller controls the movement of the robotic arm based, at least in part, on the processed images acquired by the cameras and the processor. The arm is controllably moveable to position the tool at a desired orientation and position relative to the body surface to perform transplantation of hairs.
In utilizing any of these systems and methods for hair transplantation, it is desirable to first plan the transplantation to select the follicular units to be harvested and transplanted and to determine the precise location where the hairs are to be implanted. Accordingly, in planning a hair transplantation procedure, specific follicular units from a specific location on a body surface may be selected for harvesting and transplantation into a different part of the body surface. The follicular units to be transplanted may be selected based on certain criteria, for example, the type of follicular unit (i.e. F1, F2, etc.), the orientation of the hair in the follicular unit, the density of the hair, etc. However, the process of counting, and characterizing each follicular unit can be tedious and time consuming. Therefore, there is a need for a system and method for counting and/or classifying follicular units using an automated system. A system and method for classifying follicular units is described in U.S. patent application Ser. No. 11,467,268, filed on or about Aug. 25, 2006, entitled SYSTEM AND METHOD FOR CLASSIFYING FOLLICULAR UNITS, the contents of which are incorporated by reference herein in its entirety.